Analysis of N-Nitrosamine Migration from Rubber Teats and Soothers

Motoh Mutsuga, Miku Yamaguchi, Yoko Kawamura

Division of Food Additives, National Institute of Health Sciences, Tokyo, Japan.

DOI: 10.4236/ajac.2013.46035                

Abstract

A testing method for N-nitrosamines and N-nitrosatable substances in rubber teats and soothers was modified. N-Nitrosamines are generally analyzed using either a nitrogen chemiluminescence detector (NCD) or a thermal energy analyzer (TEA). However, because few testing laboratories are equipped with these devices, it is difficult to conduct these tests. Therefore, an analysis method for N-nitrosamines using the more widespread gas chromatography-mass spectrometry (GC-MS) method was improved. In addition, EN 12868 was used to prepare the test solutions because of its worldwide use and compliance with EU regulations. Using GC-MS, EN 12868 method targeting ten kinds of N-nitrosamines was modified. The determination limits of the method were 1.0 -1.5 μg/kg for N-nitrosamines and 4 -6 μg/kg for N-nitrosatable substances. Quantification was possible at 1/5 or less and 1/15 or less, respectively, of the regulation values listed in EU Directive 93/11/EEC. In terms of application, there were no problems with the selectivity of the detector. The recoveries were 58% -109% for N-nitrosamines and 59% -102% for N-nitrosatable substances. Screening and verification were possible by measuring the amount of secondary amines in the boiled solution and migration solution.

Keywords

N-Nitrosamine; N-Nitrosatable Substances; Secondary Amine; Rubber Teat and Soother; GC-MS

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	International Agency of Research Cancer, “IARC Monographs on the Evaluation of Carcinogenic Risks to Humans,” Some N-Nitrosamines Compounds, 1998.
[2]	K. Wakabayashi, “Co-Mutagenic Effect of Norharman with N-Nitrosamine Derivatives,” Mutation Research, Vol. 80, No. 1, 1981, pp. 1-7. doi:10.1016/0027-5107(81)90172-X
[3]	B. L. Pool, et al., “Detection of Mutations in Bacteria and of DNA Damage and Amplified DNA Sequences in Mammalian Cells as a Systematic Test Strategy for Elucidating Biological Activities of Chemical Carcinogens,” Food Chemical Toxicology, Vol. 24, No. 6-7, 1986, pp. 685-691. doi:10.1016/0278-6915(86)90158-4
[4]	B. G. Boyes, et al., “Evaluation of Genotoxicity of N-Nitrosodibenzylamine in Chinese Hamster V79 Cells and Salmonella,” Mutation Research, Vol. 241, No. 4, 1990, pp. 379-385. doi:10.1016/0165-1218(90)90068-D
[5]	J. Jiao, et al., “Analysis of Tissue-Specific lacZ Mutations Induced by N-Nitrosodibenzylamine in Transgenic Mice,” Carcinogenesis, Vol. 18, No. 11, 1997, pp. 2239- 2245. doi:10.1093/carcin/18.11.2239
[6]	The Commission of the European Communities, “Commission Directive 93/11/EEC Concerning the Release of the N-Nitrosamines and N-Nitrosatable Substances from Elastomer or Rubber Teats and Soothers,” 1993.
[7]	ASTM International, “ASTM F1313-90 Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers,” 2005.
[8]	European Committee for Standardization, “EN 12868 Child Use and Care Articles-Methods for Determining the Release of N-Nitrosamines and N-Nitrosatable Substances from Elastomer or Rubber Teats and Soothers,” 1999.
[9]	D. C. Havery, et al., “Estimation of Volatile N-Nitrosamines in Rubber Nipples for Babies’ Bottles,” Food Chemical Toxicology, Vol. 20, No. 6, 1982, pp. 939-944. doi:10.1016/S0015-6264(82)80232-0
[10]	M. Takeuchi, et al., “Determination of Volatile N-Nitrosamines in Rubber Nipples by Gas Chromatography Using Thermal Energy Analyzer,” Analytical Sciences, Vol. 2, No. 6, 1986, pp. 577-580. doi:10.2116/analsci.2.577
[11]	N. P. Sen, et al., “Improved Method for Determination of Volatile Nitrosamines in Baby Bottle Rubber Nipples and Pacifiers,” Journal—Association of Official Analytical Chemists, Vol. 70, No. 3, 1987, pp. 434-438.
[12]	K. Mizuishi, et al., “N-Nitrosamine Content in Rubber Nipples and Pacifiers, 1988-2007,” Annual Report of Tokyo Metropolitan Institute of Public Health, Vol. 34, 1983, pp. 146-149.
[13]	K. Mizuishi, et al., “Migration of Secondary Amines from Rubber Nipples and Pacifiers, and Formation of Nitrosamines,” Annual Report of Tokyo Metropolitan Institute of Public Health, Vol. 35, 1984, pp. 127-132.
[14]	K. Mizuishi, et al., “Hygienic Chemical Survey on Rubber Nursing Products Migrating and Material Test for Nipples and Pacifiers,” Annual Report of Tokyo Metropolitan Institute of Public Health, Vol. 37, 1986, pp. 145- 148.
[15]	K. Mizuishi, et al., “Hygienic Chemical Survey on Rubber Products Content of N-Nitrosamines in Nipples and Pacifiers,” Annual Report of Tokyo Metropolitan Institute of Public Health, Vol. 39, 1988, pp. 97-100.
[16]	M. Kuni, et al., “On N-Nitrosamines Migrating from Toys and Rubber Apparatuses,” Food Sanitation Research, Vol. 36, No. 7, 1986, pp. 39-49.
[17]	T. Tatsuno, et al., “Hygienic Studies on Rubber Nipples (I). Secondary Amines in Commercial Rubber Nipples and Formation of Nitrosamines,” Bulletin of National Institute of Hygienic Sciences, Vol. 100, 1982, pp. 62-71.
[18]	H. Ishiwata, et al., “Nitrosamines in Rubber Nipples,” Bulletin of National Institute of Hygienic Sciences, Vol. 99, 1981, pp. 135-137.
[19]	K. Bouma, et al., “Migration of N-Nitrosamines, N-Nitrosatable Substances and 2-Mercaptobenzthiazol from Baby Bottle Teats and Soothers: A Dutch Retail Survey,” Food Additives and Contaminants, Vol. 20, No. 9, 2003, pp. 853-858. doi:10.1080/0265203031000156105
[20]	J. E. Grebel et al., “Solid-Phase Microextraction of N-Nitrosamines,” Journal of Chromatography A, Vol. 1117, No. 1, 2006, pp. 11-18. doi:10.1016/j.chroma.2006.03.044
[21]	B. J. Sanchez, et al., “Comparison of the Sensitivities of Seven N-Nitrosamines in Prescreened Waters Using an Automated Preconcentration System and Gas Chromatography with Different Detectors,” Journal of Chromatography A, Vol. 1154, No. 1-2, 2007, pp. 66-73.
[22]	J. H. Sung, et al., “Liquid Chromatography-Tandem Mass Spectrometry Determination of N-Nitrosamines Released from Rubber or Elastomer Teats and Soothers,” Food Additives and Contaminants, Vol. 27, No. 12, 2010, pp. 1745-1754. doi:10.1080/19440049.2010.508184
[23]	D. Feng, et al., “Determination of Volatile Nitrosamines in Latex Products by HS-SPME-GC-MS,” Chromatographia, Vol. 74, No. 11-12, 2011, pp. 817-825. doi:10.1007/s10337-011-2148-6
[24]	D. Feng, et al., “Evaluation of Simulant Migration of Volatile Nitrosamines from Latex Gloves and Balloons by HS-SPME-GC-MS,” Journal of Chromatographic Science, Vol. 50, No. 8, 2012, pp. 733-738. doi:10.1093/chromsci/bms057
[25]	European Committee for Standardization, “EN 1400 Child Use and Care Articles—Soothers for Babies and Young Children-Chemical Requirements and Tests,” 2002.